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The UK National Cancer Research Institute (NCRI) AML17 trial (ISRCTN55675535) was a large prospective phase III multicenter study for patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome that ran consecutively between May 2002 and December 2014 in the United Kingdom, Denmark, and New Zealand and addressed several randomized questions.1 In this AML17 trial, the safety and efficacy of daunorubicin combined with clofarabine (DClo) was prospectively compared with fludarabine/cytosine arabinoside (ara-C)/granulocyte stimulating factor (G-CSF) and idarubicin (FLAG-Ida) in patients with high-risk AML. The results of this part of the AML17 trial were reported in Leukemia by Alan K. Burnett and colleagues.2
Three-hundred and eleven patients with high-risk AML were randomized after having received the first induction course, which could have been ara-C/daunorubicin/etoposide alone (n = 39) or in combination with gemtuzumab ozogamicin 3 mg/m2 (n = 29) or 6 mg/m2 (n = 22) with the daunorubicin dose being 60 mg/m2 (n = 78) or 90 mg/m2 (n = 78). Patients were randomized 2:1 to receive up to three courses of DClo (daunorubicin 50 mg/m2 on days 1, 3 and 5 and clofarabine 20 mg/m2 days 1–5, n = 207) or FLAG-Ida (fludarabine [30 mg/m2 days 2–6], ara-C [2 g/m2] G-CSF [263 µg days 1–7] and idarubicin [8 mg/m2 days 4–6], n = 104). The main objectives of the study were the number of patients delivered to transplant and overall survival (OS).
In summary, there was no significant difference in the number of patients delivered to transplant in both the DClo and FLAG-Ida arms. However, FLAG-Ida led to a better OS in patients than DClo, which the researchers say might be due to the better RFS observed in patients after transplant.
The authors concluded that compared to DClo, FLAG-Ida was superior in patients with high-risk AML. They, however, suggested that the resulting prolonged cytopenia from the FLAG-Ida regimen can “cause unpredictable difficulties and scheduling of transplant” and thus advised that “checking the marrow status 10–14 days after the chemotherapy and proceeding to transplant irrespective of count recovery may be the optimal option”.
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